The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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11926–11950 of 13803

  • ModerateFDA (Devices)·Z-0982-2022·2022-04-27

    Oral RNA Collection Kit Recalled Due to Stabilizer Evaporation

    DNA Genotek Inc. is recalling ORAcollect RNA: ORE-100 kits due to evaporation of the stabilizing liquid, which reduces shelf life. Approximately 17,080 units are affected, including lot YJ530.

    Product
    ORAcollect RNA: ORE-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0984-2022·2022-04-27

    Beckman Coulter IRISpec CA Control glucose measurement failures recalled

    Beckman Coulter is recalling IRISpec CA/CB/CC control kits due to failures in glucose measurement for the CA Control component. The recall affects laboratory quality control products distributed worldwide.

    Product
    Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0956-2022·2022-04-27

    Abbott TactiCath Ablation Catheter Disabled by Preprogrammed First-Use Date

    Abbott is recalling 2,134 TactiCath ablation catheters manufactured with a preprogrammed 'First Use Date' that disables the device. Affected devices with 37 specific lot numbers were distributed in the U.S. and 21 other countries.

    Product
    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0971-2022·2022-04-27

    X-Ray Imaging System Cooling Circuit Failure Recall

    Siemens is recalling Artis zee floor MN X-ray systems due to a potential cooling circuit malfunction. If coolant drops below adequate levels, the X-ray tube may not cool properly and the system will automatically shut down.

    Product
    Artis zee floor MN, Model Number 10094142
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0949-2022·2022-04-27

    Terumo Cardiovascular Procedure Kit Recall for Shipping Damage

    Terumo Cardiovascular Systems Corp is recalling two lots of cardiovascular procedure kits due to packaging damage that occurred during shipping. The recall affects 64 units distributed in California and Indiana.

    Product
    Cardiovascular Procedure Kit catalog # 76645 & 73806
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2022·2022-04-27

    X-ray Imaging System Cooling Failure May Cause Tube Overheating

    Siemens Artis zee ceiling X-ray systems may fail to cool the X-ray tube if the coolant level drops. The system will automatically block X-ray emissions and display warning messages to prevent equipment damage.

    Product
    Artis zee ceiling, Model Number 10094137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0948-2022·2022-04-27

    Baxter Syringe Tip Caps Recalled Due to Incorrect Labeling

    Baxter is recalling DISCPAC syringe tip caps that are mislabeled as self-righting when they do not possess this capability, risking improper use in medical procedures.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0980-2022·2022-04-27

    Artis Q.zen Biplane X-ray Systems Coolant Level Failure Recall

    Siemens is recalling 69 Artis Q.zen biplane systems where coolant levels may drop sufficiently to prevent adequate X-ray tube cooling, triggering automatic shutdown safeguards.

    Product
    Artis Q.zen biplane, Model Number 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0981-2022·2022-04-27

    Oral DNA Collection Device Recalled for Evaporating Stabilizing Liquid

    DNA Genotek Inc. is recalling ORAcollect Dx oral DNA collection devices because the stabilizing liquid can evaporate, reducing shelf life and potentially affecting sample preservation.

    Product
    ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0955-2022·2022-04-27

    Inactivated Mycoplasma genitalium reference material recalled due to inadequate QC

    Microbiologics Inc is recalling an inactivated Mycoplasma genitalium reference material (Catalog # HE0070N, Lot HE0070-01-1) because the quality control process did not meet specification requirements.

    Product
    Inactivated macrolide-resistant Mycoplasma genitalium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0954-2022·2022-04-27

    Medical Device Reference Standard Recalled for Inadequate Quality Control Process

    Microbiologics Inc recalls an inactivated Mycoplasma genitalium reference standard (Lot HE0069-02-1) because its quality control process did not meet specification requirements. This reference material is used in diagnostic and laboratory testing.

    Product
    Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0918-2022·2022-04-20

    Cub 2 Enclosed Bed Canopy System Recalled Due to Potential Misuse

    Sensory Medical Inc recalled 225 units of the Cub 2 Enclosed Bed Canopy System for potential misuse risk. The firm is updating product warnings and precautions for devices distributed before December 16, 2021.

    Product
    Cub 2 Enclosed Bed Canopy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2022·2022-04-20

    CLARAVUE Pre-wired Electrode fails to meet electrical safety specification

    Graphic Controls' CLARAVUE Pre-wired Electrode units fail to meet electrical safety specifications required for defibrillation. The device delivers an inefficient electrical charge and may result in ineffective defibrillation.

    Product
    CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2022·2022-04-20

    Siemens Atellica CH Hemoglobin A1c Reagent Kits Recalled for Quality Control Issues

    Siemens Healthcare is recalling Atellica CH Hemoglobin A1c reagent kits due to potential reagent carryover affecting quality control and patient test results. The issue may cause inaccurate diabetes monitoring measurements.

    Product
    Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0935-2022·2022-04-20

    ECG Electrode Set Fails Electrical Safety, May Prevent Effective Defibrillation

    Graphic Controls' CLARAVUE pediatric electrode set fails electrical safety standards. The device may not deliver adequate charge during defibrillation, potentially rendering emergency treatment ineffective.

    Product
    CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0899-2022·2022-04-20

    iTotal Identity Knee Replacement System—incorrect tibial base plate packaged

    Conformis is recalling specific units of the iTotal Identity Posterior Stabilised Knee Replacement System due to incorrect tibial base plate implants being packaged in surgical kits.

    Product
    iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0942-2022·2022-04-20

    ARIA Radiation Therapy Management Software May Cause Treatment Location Error

    Varian ARIA radiation therapy management software versions 13.6 through 16.1 may generate incorrect treatment plan values that could direct radiation therapy to the wrong location. No illnesses have been reported.

    Product
    ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0900-2022·2022-04-20

    FDA Updates Labeling for LIPOSORBER LDL Adsorption Column Due to Anaphylactoid Shock Risk

    LIPOSORBER LA-15 LDL Adsorption Column labeling has been updated to address a risk of severe anaphylactoid reactions and shock in patients receiving treatment while taking ACE inhibitors.

    Product
    LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (L
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0920-2022·2022-04-20

    Verigene Processor SP Recalled for No Call Results

    Luminex Corporation is recalling 4 Verigene Processor SP diagnostic devices that repeatedly failed to produce results, returning No Call outputs instead. Two of three customer complaints involved this malfunction.

    Product
    Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0906-2022·2022-04-20

    Integra Universal Flexible Arm Recall: Internal Cable May Break

    Integra LifeSciences is recalling the Universal Flexible Arm (part number REF 1362275) because excess tightening force can break the internal cable at the tip, rendering the device unusable.

    Product
    Integra Universal Flexible Arm part number REF 1362275
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2022·2022-04-20

    Hemodialysis Conductivity Sensors recalled for potential cracks and dialysate leaks

    B Braun Medical Inc is recalling conductivity sensors used in Dialog hemodialysis systems due to potential cracking during use, which could cause leaks in the dialysate circuit and improper ultrafiltration. Affected patients should contact their healthcare provider.

    Product
    Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S (UDI 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2022·2022-04-20

    Pre-wired ECG Electrode Set Fails Defibrillation Voltage Safety Standard

    Graphic Controls' CLARAVUE Pre-wired Electrode set does not meet required electrical specifications for defibrillation use. The device fails to withstand 5,000 volts without breakdown, potentially resulting in ineffective defibrillation.

    Product
    CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2022·2022-04-20

    Nextra Hammertoe Correction System surgical instruments recalled for defective connector

    Nextremity Solutions recalls 459 units of the Nextra Hammertoe Correction System due to an oversized proximal driver end that prevents proper connection and removal during surgery.

    Product
    Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2022·2022-04-20

    Abbott Vascular Plus 30 Priority Pack Recalled for Connection Leaks

    Abbott Vascular is recalling seven lots of the Plus 30 Priority Pack due to increased reports of leaks and intermittent loose connections in the vascular devices.

    Product
    Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0910-2022·2022-04-20

    Orthopedic Surgical Instrument Kit Recalled for Improper Driver Fit

    The Nextra Hammertoe Correction System surgical kit is being recalled due to an oversized driver that cannot properly connect to and remove from the implant. This defect can delay surgery.

    Product
    Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide